Chlorhexidine gluconate 0.2% mouthwash peppermint

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Chlorhexidine gluconate
Available from:
Thornton & Ross Ltd
ATC code:
A01AB03
INN (International Name):
Chlorhexidine gluconate
Dosage:
2mg/1ml
Pharmaceutical form:
Mouthwash
Administration route:
Oromucosal
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 12030400; GTIN: 5011309014310
Authorization number:
; PL 00240/0118

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Data Matrix:

23053506 VERIFIED

PCP Header Box

Approved by

Date

Operator

Artwork No

CRN

fix

Reason f

Suf

or

Change

Issued by

Date

MHRA/IMB

submission

required

gill.kennedy

561598

11985

Addition of 'Peppermint Flavour'

at request of Marketing

MHRA Header Box

Product

Title

C

Fonts Used

olours Used

Component

Pack Size

IG Code

Dimensions

Proof No.

Date

Landscape peelable label

300ml

23053506

65 x 170mm

10.03.2015

Process Cyan

Process Magenta

Process Yellow

Process Black

Keyline (Does not print)

Braille

Text free area (Does not print)

Care Chlorhexidine Digluconate 0.2%

w/v Antiseptic Mouthwash

Helvetica

Helvetica Neue LT

Optima BQ

Treats & prevents gum disease

Care

Chlorhexidine

Digluconate 0.2% w/v

Antiseptic Mouthwash

Peppermint Flavour

Peel

Here

300ml

IMPORTANT: Peel this label

at corner and read BEFORE

use. Do not tear off, re-fix for

future use.

For the treatment and prevention of gingivitis

(gum disease), gum ulceration, oral thrush,

denture sores and for maintaining oral

hygiene.

Use the solution only in the mouth. Do not

swallow.

Adults, the elderly and children:

Measure 10ml in the cup provided.

Rinse the mouth thoroughly for about

1 minute, then spit out.

Use twice a day.

Gingivitis (gum disease): Use as above for

one month.

Mouth ulcers and thrush: Use as above,

continuing for 2 days after symptoms go.

Denture sores: Use as above, also soak

dentures for 15 minutes, twice a day.

If symptoms persist, stop use and

consult your doctor or dentist.

Peel where shown for further

precautions.

Active ingredient: chlorhexidine digluconate

0.2% w/v.

Also contains: ethanol, castor oil polyoxyl

hydrogenated, menthol, peppermint oil,

aspartame (E951) and purified water.

Alcohol 7 vol%.

Do not store above 25°C. Once opened use

within 28 days.

Keep out of the sight and reach of children.

Manufactured by the licence holder Thornton

and Ross Ltd., Huddersfield, HD7 5QH, UK.

PL 00240/0118 PIP: 300-7994

23053506

This mouthwash contains chlorhexidine digluconate,

a disinfectant and antiseptic. It reduces the

formation of dental plaque and fights infection in the

mouth.

1. Before you use this medicine

Do not take/use the medicine if you or

your child....

Are allergic (hypersensitive) to chlorhexidine

gluconate or any of the other ingredients listed on

the front.

Special warnings and precautions

This medicine may in rare cases cause severe

allergic reactions, leading to a drop in blood pressure

and even unconsciousness. Early symptoms of a

severe allergic reaction may be skin rash or asthma.

If you notice these symptoms, stop use and contact

your doctor as soon as possible (see under section 2:

Possible side effects).

Take care with the medicine….

Keep away from the eyes and ears.

If the solution comes in contact with the eyes,

rinse well with water.

Toothpastes may stop the mouthwash working

properly if used immediately after the mouthwash.

To prevent this use toothpaste first or at a different

time of day and rinse your mouth before using the

mouthwash.

Pregnant or breastfeeding….

Ask your doctor or pharmacist for advice before using

this medicine if you are pregnant, might be pregnant

or are breastfeeding. Chlorhexidine Digluconate

Antiseptic Mouthwash should not be used unless the

doctor has told you to do so.

Important ingredient information

This product contains aspartame, a source of

phenylalanine, which may be harmful for people

with phenylketonuria.

It also contains castor oil polyoxyl hydrogenated

which may cause skin reactions.

If you notice the following minor effects it is not

normally necessary to stop use, however, if

concerned talk to your doctor or pharmacist.

Taste changes or a burning sensation on the

tongue when first used. This usually reduces with

continued use.

Discolouration of the tongue and teeth may occur,

but this is not permanent and may be prevented by

brushing daily with a normal toothpaste before

using the mouthwash and avoiding tannin-containing

foods such as red wine, tea or coffee for at least an

hour after using the mouthwash.

In some cases a scale and polish by your dentist

or hygienist may be necessary to remove the

discolouration completely.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide

more information on the safety of this medicine.

3. Further information

If you accidentally swallow some see a doctor

straight away. Take the pack with you to show which

medicine you have swallowed.

Do not use after the expiry date. The expiry date

refers to the last day of that month.

Return any unused medicine to the pharmacy for

disposal.

What the medicine looks like

Chlorhexidine Digluconate Antiseptic Mouthwash is a

colourless liquid with an odour of peppermint.

It is supplied in 300ml bottles.

This label was revised in March 2015

23053506

23053506

2. Possible side effects

Like all medicines, Chlorhexidine Digluconate

Antiseptic Mouthwash can have side effects, although

these don’t affect everyone.

Possible serious side effects

If you notice any of the following reactions stop use

and get immediate medical help: swelling of the face,

lips, tongue or throat; a red itchy skin rash; wheezing

or difficulty breathing; feeling faint or dizzy; a strange

metallic taste in the mouth; collapse. You may be

having an allergic reaction.

Other possible side effects are:

Skin irritation.

Swelling of the salivary glands.

Peeling of the skin inside the mouth.

If you notice these side effects, stop use and tell your

doctor or pharmacist. They will tell you what to do.

LOT, MAN & EXP

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Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Care Chlorhexidine Digluconate 0.2% w/v Antiseptic Mouthwash

Peppermint Flavour

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine

Digluconate

0.2%

(equivalent

Chlorhexidine

Gluconate

Solution 1.0% v/v)

For excipients see 6.1

3

PHARMACEUTICAL FORM

Mouth wash.

A clear, colourless liquid with an odour of menthol and peppermint.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Aids prevention of dental plaque formation. Aids the treatment and prevention of

gingivitis. For the maintenance of oral hygiene. Promotes gingival healing following

periodontal surgery. Management of recurrent oral ulceration. For the treatment of

denture stomatitis and oral thrush.

4.2

Posology and method of administration

For oromucosal use.

Adults, the elderly and children: To be used as required up to twice daily. Rinse the

mouth thoroughly for about 1 minute with 10ml. The mouthwash should be expelled

from the mouth after rinsing.

Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1 minute. The

mouthwash should be expelled from the mouth after rinsing.

Treatment of gingivitis: A course of one month is recommended.

Treatment of denture stomatitis: Soak the denture(s) in solution for 15 minutes twice

daily.

Treatment of oral ulceration and oral thrush: Treatment should be continued for 48

hours after clinical resolution.

4.3

Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a

history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

4.4

Special warnings and precautions for use

For oral use only. Keep away from the eyes and ears. If the solution comes into contact with

the eyes, rinse well with water. Keep out of the reach and sight of children. Do not swallow.

If symptoms persist, stop using and consult your doctor or dentist.

Chlorhexidine Mouthwash contains chlorhexidine. Chlorhexidine is known to induce

hypersensitivity, including generalised allergic reactions and anaphylactic shock. The

prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests

this is likely to be very rare. Chlorhexidine Mouthwash should not be administered to anyone

with a potential history of an allergic reaction to a chlorhexidine-containing compound (see

sections 4.3 and 4.8).

4.5

Interaction with other medicinal products and other forms of interaction

Chlorhexidine digluconate is incompatible with anionic agents which are usually

present in conventional dentrifices. These should therefore be used before the

mouthwash. Rinse the mouth thoroughly with water before using the mouthwash.

4.6

Pregnancy and lactation

No harmful effects in human pregnancy or during lactation have been reported.

Nevertheless like all medicines, care should be exercised and the mouthwash should

only be used on the advice of a doctor or dentist

4.7

Effects on ability to drive and use machines

No or negligible influence.

4.8

Undesirable effects

Skin disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema,

rash, urticaria, skin irritation, and blisters.

Immune disorders

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and

4.4).

A superficial discolouration of the dorsum of the tongue may occur which disappears after

discontinuation of treatment. Discolouration of the teeth and silicate or composite

restorations may also occur. The discolouration is not permanent and may be prevented by

brushing daily with conventional toothpaste prior to using the mouthwash and avoiding

tannin-containing food and drinks. In some cases a professional prophylaxis (scaling and

polishing) may be necessary to completely remove the stain.

Transient disturbances of taste and a burning sensation of the tongue may

occur on initial use of the mouthwash but usually diminishes with continued use.

In cases where oral desquamation occurs it may be necessary to discontinue treatment.

Very occasionally, swelling of the parotid glands during use has been reported. If this

happens stop using the product and the effect should go away.

In all cases spontaneous resolution has occurred on discontinuation of treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow

Care Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose

Chlorhexidine is poorly absorbed by the oral route, therefore systemic effects are

unlikely even if large volumes are swallowed. However, gastric lavage followed by

supportive measures may be used as appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

A01A B03 – Stomatological preparations, antiinfectives for local oral treatment

Chlorhexidine digluconate is a bisbiguanide antiseptic and disinfectant, which is

bactericidal or bacteriostatic against a wide range of gram negative and gram positive

vegetative

bacteria,

yeasts,

dermatophyte

fungi

lipophilic

viruses.

antimicrobial activity covers most of the important species occurring in the oral

microflora.

5.2

Pharmacokinetic properties

Due to its cationic nature, chlorhexidine digluconate binds strongly to skin, mucosa

and other tissues and is thus very poorly absorbed. No detectable blood levels have

been found following oral use.

5.3

Preclinical safety data

No data of relevance to the prescriber, which is additional to that included in other

sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Hydrogenated Polyoxyl Castor Oil

Menthol

Peppermint Oil

Ethanol (96%)

Aspartame E951

Purified Water

6.2

Incompatibilities

Care Chlorhexidine Antiseptic Mouthwash is incompatible with anionic agents which

often

present

toothpastes.

Therefore

these

should

used

before

mouthwash, rinsing the mouth between applications, or at a different time of day.

6.3

Shelf life

Unopened: 2 years

In-use: 28 days

6.4

Special precautions for storage

Do not store above 25°C.

6.5

Nature and contents of container

300ml amber PET bottle with HDPE/PP tamper evident child resistant closure with

EPE Saranex liner.

30ml CE marked polypropylene dosing cup.

6.6

Special precautions for disposal

Not applicable.

7

MARKETING AUTHORISATION HOLDER

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)

PL 00240/0118

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

09/07/2009

10

DATE OF REVISION OF THE TEXT

09/04/2015

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